Status:

RECRUITING

Adolescent Mood During Puberty and Testosterone

Lead Sponsor:

University of North Carolina, Chapel Hill

Collaborating Sponsors:

Foundation of Hope, North Carolina

Conditions:

Adolescent Depression

Eligibility:

All Genders

11-14 years

Phase:

NA

Brief Summary

Starting at puberty, female adolescents are nearly three-times more likely to develop internalizing disorders, like depression, while male adolescents are two-times more likely to develop externalizin...

Eligibility Criteria

Inclusion

  • Between the ages of 11 and 14
  • Have their own personal mobile device and capability to download the MyCap and Healthy Minds apps
  • Experienced a stressful life event within the last year, or endorse moderate depression (defined by a CES-DC score 16 or higher)

Exclusion

  • Previous experience with the Healthy Minds Program
  • Regular meditation practice
  • Current or history of manic episodes, psychotic symptoms, or current suicidal intent
  • Taking any form of exogenous hormones or intrauterine device (IUD) within one month of participation in the study
  • Taking medications that directly alter cardiovascular or neurological function

Key Trial Info

Start Date :

August 24 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2027

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06072677

Start Date

August 24 2023

End Date

December 1 2027

Last Update

October 18 2024

Active Locations (1)

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1

Carolina Crossing B, Suite 1

Chapel Hill, North Carolina, United States, 27517